Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:
Schedule
Product: Azamun
Active Ingredient: Azathioprine 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Manufacturing Limited, Auckland, New Zealand
Product: Azamun
Active Ingredient: Azathioprine 75mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Manufacturing Limited, Auckland, New Zealand
Product: Azamun
Active Ingredient: Azathioprine 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Manufacturing Limited, Auckland, New Zealand
Product: m-Finasteride
Active Ingredient: Finasteride 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturers: Famar SA, Athens, Greece
Kleva SA, Athens, Greece
Product: Striverdi Respimat
Active Ingredient: Olodaterol hydrochloride 2.7mcg equivalent to Olodaterol 2.5mcg
Dosage Form: Solution for inhalation
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer: Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany
Product: Zimybe 10/10
Active Ingredients: Ezetimibe 10mg
Simvastatin 10mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra State, India
Product: Zimybe 10/20
Active Ingredients: Ezetimibe 10mg
Simvastatin 20mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra State, India
Product: Zimybe 10/40
Active Ingredients: Ezetimibe 10mg
Simvastatin 40mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra State, India
Product: Zimybe 10/80
Active Ingredients: Ezetimibe 10mg
Simvastatin 80mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra State, India
Dated this 20th day of June 2014.
STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).